Chronic Kidney Disease Requiring Chronic DialysisTfh-CKDNCT06635525
Impact Of Kidney Failure On The Regulation Of Humoral Response To Vaccination
An observational study of Chronic Kidney Disease Requiring Chronic Dialysis and Vaccine Response, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 3 sites in Italy.
Trial summary
The aim of this observational study is to determine if and how kidney failure affects the development of protective immune responses following vaccination in patients on chronic dialysis. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease Requiring Chronic Dialysis, Vaccine Response
- What is being tested?
- Influenza vaccination and SARS-CoV-2 vaccine
- Type of treatment
- Vaccines
- How many people
- 146 participants
- Where
- 3 sitesItaly
- Study dates
- 16 Oct 2024to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study populations consist of (1) subjects with advanced chronic kidney disease requiring thrice-weekly hemodialysis, (2) subjects with advanced chronic kidney disease on peritoneal dialysis, and (3) subjects without a prior medical history of chronic kidney disease, who are eligible to receive an influenza vaccine according to standard clinical practice guidelines.
Who may be able to join
- Age between 18 and 70 years
- Patients undergoing thrice-weekly hemodialysis / peritoneal dialysis for at least 3 months OR healthy individuals without a history of renal insufficiency
- Subjects eligible to receive a seasonal influenza vaccine
- Signed informed consent for participation in the study
Who cannot join
- Recent influenza infection (clinically resolved less than 3 months ago).
- Administration of immunosuppressive drugs in the two weeks prior to vaccination.
- Administration of another vaccine in the three weeks prior to enrollment (co-administration of other vaccines with those under study does not contraindicate participation).
- Systemic infection clinically resolved less than two weeks before enrollment.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Giuseppe Castellano, MD, PhD contact
Italy3 sites, 3 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
- Not yet recruiting
ASST Santi Paolo e Carlo
Milan, 20142
- Not yet recruiting
ASST Fatebenefratelli Sacco
Milan, 20157
About this study
The aim of this observational study is to determine if and how kidney failure affects the development of protective immune responses following vaccination in patients on chronic dialysis.
Researchers will compare the effectiveness of the influenza vaccine in inducing protective antibodies between hemodialysis patients and subjects without chronic kidney disease.
Participants will:
- Be enrolled at the time of influenza vaccination
- Visit the clinic at 7, 14, 30, 60, and 120 days after vaccination
- Be asked to provide relevant clinical information and a blood sample at each visit
- Being tested
- Influenza vaccination, SARS-CoV-2 vaccine
- Keywords
- Vaccine, Influenza, Chronic Kidney Disease, Hemodialysis, Peritoneal dialysis, Humoral Response
- Medical subject headings
- Influenza, Human, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza vaccinationBiological
Single-dose
SARS-CoV-2 vaccineBiological
Single-dose
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis patients | Subjects with advanced chronic kidney disease requiring thrice-weekly hemodialysis Receives: Biological: Influenza vaccination; Biological: SARS-CoV-2 vaccine | |
| Peritoneal dialysis patients | Subjects with advanced chronic kidney disease on peritoneal dialysis Receives: Biological: Influenza vaccination; Biological: SARS-CoV-2 vaccine | |
| Healthy controls | Subjects without a prior history of chronic kidney disease Receives: Biological: Influenza vaccination; Biological: SARS-CoV-2 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of serological response to influenza vaccination
Measured: From enrollment to 30±3 days after vaccination
Secondary outcomes (5)
Titer of influenza-specific antibodies after vaccination
Measured: From enrollment to 30±3 days after vaccination
Correlation between virus-specific antibody concentration after influenza vaccination and the frequency of circulating T follicular helper cell subsets
Measured: From enrollment to 120±5 days after vaccination
Degree of antigen-specific activation of T follicular helper and B cells in vitro after influenza vaccination
Measured: From enrollment to 120±5 days after vaccination
Degree of polyclonal activation of T follicular helper and B cells in vitro after exposure to the serum of subjects vaccinated against influenza
Measured: From enrollment to 120±5 days after vaccination
Single-cell transcriptome expression in circulating T follicular helper cell subsets
Measured: From enrollment to 120±5 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start16 Oct 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Requiring Chronic DialysisStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Cariplo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635525
- Sponsor's protocol ID
- 5281
- Acronym
- Tfh-CKD
- Status last verified
- Mar 2026
- First submitted
- 8 Oct 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Of Kidney Failure On The Regulation Of Humoral Response To Vaccination
- ClinicalTrials.gov ID
- NCT06635525
- Acronym / sponsor ID
- Tfh-CKD / 5281
- Keywords
- Vaccine, Influenza, Chronic Kidney Disease, Hemodialysis, Peritoneal dialysis, Humoral Response
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- Fondazione Cariplo
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this observational study is to determine if and how kidney failure affects the development of protective immune responses following vaccination in patients on chronic dialysis.
Researchers will compare the effectiveness of the influenza vaccine in inducing protective antibodies between hemodialysis patients and subjects without chronic kidney disease.
Participants will:
- Be enrolled at the time of influenza vaccination
- Visit the clinic at 7, 14, 30, 60, and 120 days after vaccination
- Be asked to provide relevant clinical information and a blood sample at each visit
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis patients | – | Biological: Influenza vaccination, Biological: SARS-CoV-2 vaccineSubjects with advanced chronic kidney disease requiring thrice-weekly hemodialysis |
| Peritoneal dialysis patients | – | Biological: Influenza vaccination, Biological: SARS-CoV-2 vaccineSubjects with advanced chronic kidney disease on peritoneal dialysis |
| Healthy controls | – | Biological: Influenza vaccination, Biological: SARS-CoV-2 vaccineSubjects without a prior history of chronic kidney disease |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study populations consist of (1) subjects with advanced chronic kidney disease requiring thrice-weekly hemodialysis, (2) subjects with advanced chronic kidney disease on peritoneal dialysis, and (3) subjects without a prior medical history of chronic kidney disease, who are eligible to receive an influenza vaccine according to standard clinical practice guidelines.
Key inclusion criteria (4 listed)
- Age between 18 and 70 years
- Patients undergoing thrice-weekly hemodialysis / peritoneal dialysis for at least 3 months OR healthy individuals without a history of renal insufficiency
- Subjects eligible to receive a seasonal influenza vaccine
- Signed informed consent for participation in the study
Key exclusion criteria (4 listed)
- Recent influenza infection (clinically resolved less than 3 months ago).
- Administration of immunosuppressive drugs in the two weeks prior to vaccination.
- Administration of another vaccine in the three weeks prior to enrollment (co-administration of other vaccines with those under study does not contraindicate participation).
- Systemic infection clinically resolved less than two weeks before enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza vaccinationSingle-dose | Biological | Healthy controls, Hemodialysis patients, Peritoneal dialysis patients |
| SARS-CoV-2 vaccineSingle-dose | Biological | Healthy controls, Hemodialysis patients, Peritoneal dialysis patients |
Primary outcome
Frequency of serological response to influenza vaccination
Time frame: From enrollment to 30±3 days after vaccination
5 secondary outcomes
Titer of influenza-specific antibodies after vaccination
Time frame: From enrollment to 30±3 days after vaccination
Correlation between virus-specific antibody concentration after influenza vaccination and the frequency of circulating T follicular helper cell subsets
Time frame: From enrollment to 120±5 days after vaccination
Degree of antigen-specific activation of T follicular helper and B cells in vitro after influenza vaccination
Time frame: From enrollment to 120±5 days after vaccination
Degree of polyclonal activation of T follicular helper and B cells in vitro after exposure to the serum of subjects vaccinated against influenza
Time frame: From enrollment to 120±5 days after vaccination
Single-cell transcriptome expression in circulating T follicular helper cell subsets
Time frame: From enrollment to 120±5 days after vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giuseppe Castellano, MD, PhD contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease Requiring Chronic Dialysis and Vaccine Response, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manuel A Podesta', MD, PhD (0039 0255034568, manuel.podesta@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of serological response to influenza vaccination (time frame: From enrollment to 30±3 days after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.